Surgiwand II 178093Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 10884523000900), received between Jun 7, 2016 and Feb 4, 2025 — classified as 3 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Break” (48 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 5, 2021Class IIOpen, Classified

   Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.

   Z-1411-2021 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO USE, THE DISTAL TIP OF THE BLACK SHEATH OF THE DEVICE WITH CAUTERY WAS DAMAGED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 21305924 ↗
• MalfunctionJan 21, 2025Melted; Melted

  IT WAS REPORTED THAT PREOPERATIVELY, THE DISTAL TIP OF THE BLACK SHEATH OF THE SURGIWAND WAS DAMAGED AND APPEARED TO BE MELTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201293 ↗
• MalfunctionJul 1, 2024Melted; Melted

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVER METASTASECTOMY, AT THE TIME OF USING THE DEVICE IN THE ABDOMINAL CAVITY, THE DISTAL TIP OF THE BLACK SHEATH WAS DAMAGED; IT WAS MELTED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645211 ↗
• MalfunctionSep 12, 2023Melted; Detachment of Device or Device Component; Melted; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TRANSVAGINAL HYDRO LAPAROSCOPY (THL) PROCEDURE, WHEN ACTIVATION OF THE ELECTRODE, THE INSTRUMENT MELTED AND THE PLASTIC COATING FELL INTO THE PATIENT'S CAVITY. THE PLASTIC COATING WAS RETRIEVED WITH FORCEPS. IT WAS OCCURRED ON TWO DEVICES. TO RESOLVE THE ISSUE, THE PROCEDURE WAS CONTINUED WITHOUT THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17731136 ↗
• MalfunctionSep 12, 2023Melted; Detachment of Device or Device Component; Melted; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TRANSVAGINAL HYDRO LAPAROSCOPY (THL) PROCEDURE, WHEN ACTIVATION OF THE ELECTRODE, THE INSTRUMENT MELTED AND THE PLASTIC COATING FELL INTO THE PATIENT'S CAVITY. THE PLASTIC COATING WAS RETRIEVED WITH FORCEPS. IT WAS OCCURRED ON TWO DEVICES. TO RESOLVE THE ISSUE, THE PROCEDURE WAS CONTINUED WITHOUT THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17730336 ↗
• MalfunctionAug 4, 2023Melted; Melted

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE DEVICE HAD MELTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17464110 ↗
• MalfunctionSep 8, 2022Melted; Flare or Flash; Melted; Flare or Flash

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BAND REMOVAL CONVERTED TO LAPAROSCOPIC SLEEVE GASTRECTOMY, AT THE TIME OF DISSECTION OF THE LAPAROSCOPIC BAND FOR REMOVAL, ENCAPSULATED IN STOMACH, DURING MONOPOLAR ACTIVATION, THE L-HOOK SEEMED TO MELT AND DEFORM THE DISTAL ASPIRATION SHEATH WHILE DISSECTING THE ENCAPSULATED LAP BAND FROM THE TISSUE SURROUNDING THE STOMACH, CONSISTING MOSTLY SCAR TISSUE OVERGROWTH, FAT AND OMENTUM. ANOTHER DEVICE FROM THE SAME BATCH WAS OPENED AND FURTHER MELTING OF THE DISTAL ASPIRATION SHEATH OCCURRED AGAIN. THE MONOPOLAR CORD WAS THEN DISCONNECTED FROM THE DEVICE AND ATTACHED TO AN APPLIED SCISSOR FOR FURTHER DISSECTION WITHOUT AN ISSUE. THE DEVICE WAS STILL USED FOR SUCTION AND IRRIGATION. AN ELECTROSURGICAL UNIT WITH REUSABLE MONOPOLAR CORD AND POWER WATTAGE SETTINGS OF 45 CUT AND 45 COAG. COAG WAS BEING USED DURING THE ISSUE ENCOUNTERED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15379477 ↗
• MalfunctionJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Insufficient Information

  MAUDE report 14657375 ↗
• MalfunctionJun 8, 2022Break; Device Slipped; Break; Device Slipped

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC HEPATECTOMY, BEFORE PUTTING THE DEVICE INTO THE BODY, THE BLACK SHEATH COVER BECAME LOOSE FROM THE SHAFT AND THE DISTAL TIP OF THE BLACK SHEATH GOT DAMAGED. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14636048 ↗
• MalfunctionApr 26, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ASSISTED RADICAL NEPHRECTOMY, THE DEVICE BROKE. THE PRODUCT WAS REMOVED FROM USE AND NEW PRODUCT WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14215601 ↗
• MalfunctionApr 12, 2022Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHILE PREPARING CASE, THE ITEM WAS FOUND FAULTY (CRACKED) AT THE BLACK PLASTIC TIP WHEN REMOVED FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14085345 ↗
• MalfunctionMar 28, 2022Melted; Melted

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, THE TIP MELTED WHEN BEING USED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13928534 ↗
• MalfunctionFeb 15, 2022Break; Device Slipped; Break; Device Slipped

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY, AT THE EARLY STAGE OF THE OPERATION, WHEN THE ELECTRODE WAS BEING RETRACTED, IT GOT STUCK ON THE BLACK SHEATH PART AND GOT DAMAGED. THE BLACK SHEATH COVER LOOSE FROM THE SHAFT AND THE DISTAL TIP OF THE BLACK SHEATH GOT DAMAGED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534001 ↗
• MalfunctionDec 21, 2021Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO SURGERY, THE DISTAL TIP OF THE BLACK SHEATH WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056020 ↗
• MalfunctionOct 27, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VAGINAL TOTAL HYSTERECTOMY, ON THE VAGINAL WALL, THE DISTAL END OF THE BLACK SHEATH WAS DAMAGED. IT WAS STOPPED BEING USED AND A NEW DEVICE WAS UTILIZED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705303 ↗
• MalfunctionOct 7, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE HAD A WARPED L-HOOK AND HAVE A BROKEN TIP UPON OPENING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 12591328 ↗
• MalfunctionSep 27, 2021Break; Device Slipped; Break; Device Slipped

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, ON DUCT DISSECTION, THE DEVICE BLACK SHEATH COVER LOOSED FROM THE SHAFT AND THE DISTAL TIP WAS DAMAGED. NOT ONLY BLACK SHEATH DAMAGED BUT ALSO TROCAR WAS BROKEN. TO COMPLETE THE CASE, THE DEVICE WAS REPLACED BY ANOTHER NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532080 ↗
• MalfunctionSep 24, 2021Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE WAS FOUND TO HAVE A BROKEN TIP UPON OPENING THE PACKAGING. THERE WAS NO VISIBLE DAMAGE ON THE EXTERIOR OF THE SHIPPING CONTAINER OR PACKAGING ITSELF.

  Patient problems: Insufficient Information

  MAUDE report 12526649 ↗
• MalfunctionSep 13, 2021Melted; Melted

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE SURGEON ACTIVATED THE COAGULANT ENERGY TO COAGULATE THE GALLBLADDER, THE TIP OF THE BLACK SHEATH WAS MELTED. A REUSABLE INSTRUMENT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12459050 ↗
• MalfunctionAug 17, 2021Break; Break

  ACCORDING TO THE REPORTER, UPON OPENING THE PACKAGE DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE DISTAL TIP OF THE BLACK SHEATH WAS DAMAGED. A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12330796 ↗
• MalfunctionJul 12, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGICAL SURGERY, THE INSULATING COATING OF THE HOOK TIP OF THE DEVICE WAS BROKEN DOWN AND TWISTED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12149723 ↗
• MalfunctionJun 29, 2021Break; Melted; Break; Melted

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC CHOLECYSTECTOMY WHILE DISSECTION, THE DISTAL TIP OF THE BLACK SHEATH OF THE TWO INSTRUMENT WAS DAMAGED AND HAD MELTED. IN ORDER TO RESOLVE THE ISSUE A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085080 ↗
• MalfunctionJun 29, 2021Break; Melted; Insufficient Device Problem Information; Break; Melted; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, IN DISSECTION, TWO DEVICES HAVE THE DISTAL TIP OF THE BLACK SHEATH DAMAGED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085040 ↗
• MalfunctionJun 29, 2021Break; Melted; Insufficient Device Problem Information; Break; Melted; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, IN DISSECTION, TWO DEVICES HAVE THE DISTAL TIP OF THE BLACK SHEATH DAMAGED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084971 ↗
• MalfunctionJun 8, 2021Break; Melted; Flare or Flash; Break; Melted; Flare or Flash

  ACCORDING TO THE REPORTER, WHEN DISSECTING ON A LAPAROSCOPIC PANCREATIC CANCER PROCEDURE, THE DISTAL TIP OF THE BLACK SHEATH WAS DAMAGED AND HAD BURNT AND MELTED. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11960656 ↗